FDA.reportPublic FDA data

Montelukast Sodium

Product NDC
62175-205
11-digit product format
621750205
Labeler code
62175
Product ID
62175-205_a4215d29-ef78-4b4d-9683-9dc4d35e345a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Montelukast Sodium
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Lannett Company, Inc.
Application
ANDA200405
Marketing category
ANDA
Marketing start
2012-08-03
Substance
MONTELUKAST SODIUM
Active strength
5 mg/1
Pharmacologic classes
Leukotriene Receptor Antagonist [EPC], Leukotriene Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Montelukast Sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MONTELUKAST SODIUM5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU1O3J18SFL
Rxcui242438, 311759

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
8d8a355b-240d-8c38-7331-c9e3c1068a33Product name920161220
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62175-205-32Montelukast Sodium30 in 1 BOTTLETABLET, CHEWABLE3037
62175-205-43Montelukast Sodium1000 in 1 BOTTLETABLET, CHEWABLE100037
62175-205-46Montelukast Sodium90 in 1 BOTTLETABLET, CHEWABLE9037

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62175-205-32EA - Each62175-205c7374692-da12-43e1-a100-566edffa5de612013-02-13
62175-205-43EA - Each62175-2055c5ec0c4-4ddd-4307-ae81-4b787ff7b7f012013-02-13
62175-205-46EA - Each62175-2051dbfffb1-0202-4fa9-8505-d1ae2004b8a812013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLMONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, FILM COATED [KREMERS URBAN PHARMACEUTICALS INC.]21
MONTELUKASTACTIVE MOIETYMHM278SD3EMONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, FILM COATED [KREMERS URBAN PHARMACEUTICALS INC.]21
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UMONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, FILM COATED [KREMERS URBAN PHARMACEUTICALS INC.]21
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, FILM COATED [KREMERS URBAN PHARMACEUTICALS INC.]21
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, FILM COATED [KREMERS URBAN PHARMACEUTICALS INC.]21
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, FILM COATED [KREMERS URBAN PHARMACEUTICALS INC.]21
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PMONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, FILM COATED [KREMERS URBAN PHARMACEUTICALS INC.]21
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, FILM COATED [KREMERS URBAN PHARMACEUTICALS INC.]21
MANNITOLINACTIVE INGREDIENT3OWL53L36AMONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, FILM COATED [KREMERS URBAN PHARMACEUTICALS INC.]21
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, FILM COATED [KREMERS URBAN PHARMACEUTICALS INC.]21
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, FILM COATED [KREMERS URBAN PHARMACEUTICALS INC.]21
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, FILM COATED [KREMERS URBAN PHARMACEUTICALS INC.]21
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIMONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, FILM COATED [KREMERS URBAN PHARMACEUTICALS INC.]21
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, FILM COATED [KREMERS URBAN PHARMACEUTICALS INC.]21
TALCINACTIVE INGREDIENT7SEV7J4R1UMONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, FILM COATED [KREMERS URBAN PHARMACEUTICALS INC.]21
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, FILM COATED [KREMERS URBAN PHARMACEUTICALS INC.]21
Montelukast SodiumACTIVE INGREDIENTU1O3J18SFLMONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVKARE, INC.]6
MontelukastACTIVE MOIETYMHM278SD3EMONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVKARE, INC.]6
Butylated HydroxyanisoleINACTIVE INGREDIENTREK4960K2UMONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVKARE, INC.]6
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UMONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVKARE, INC.]6
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVKARE, INC.]6
Ferric Oxide RedINACTIVE INGREDIENT1K09F3G675MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVKARE, INC.]6
hydroxypropyl celluloseINACTIVE INGREDIENTRFW2ET671PMONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVKARE, INC.]6
HypromellosesINACTIVE INGREDIENT3NXW29V3WOMONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVKARE, INC.]6
mannitolINACTIVE INGREDIENT3OWL53L36AMONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVKARE, INC.]6
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1AMONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVKARE, INC.]6
polyvinyl alcoholINACTIVE INGREDIENT532B59J990MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVKARE, INC.]6
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVKARE, INC.]6
sodium stearyl fumarateINACTIVE INGREDIENT7CV7WJK4UIMONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVKARE, INC.]6
SucraloseINACTIVE INGREDIENT96K6UQ3ZD4MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVKARE, INC.]6
talcINACTIVE INGREDIENT7SEV7J4R1UMONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVKARE, INC.]6
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPMONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVKARE, INC.]6
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLMONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVPAK]2
MONTELUKASTACTIVE MOIETYMHM278SD3EMONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVPAK]2
Butylated HydroxyanisoleINACTIVE INGREDIENTREK4960K2UMONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVPAK]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVPAK]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVPAK]2
Ferric Oxide RedINACTIVE INGREDIENT1K09F3G675MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVPAK]2
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PMONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVPAK]2
HypromellosesINACTIVE INGREDIENT3NXW29V3WOMONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVPAK]2
MANNITOLINACTIVE INGREDIENT3OWL53L36AMONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVPAK]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVPAK]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVPAK]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVPAK]2
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIMONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVPAK]2
SucraloseINACTIVE INGREDIENT96K6UQ3ZD4MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVPAK]2
TALCINACTIVE INGREDIENT7SEV7J4R1UMONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVPAK]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVPAK]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62175-205MONTELUKAST SODIUM TABLET, CHEWABLE [LANNETT COMPANY, INC.]37Current NDC, Legacy NDC, 3 package rows20230719_c43d1edb-c162-4317-9a89-d84e4eff5512.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311759montelukast sodium 4 MG Chewable TabletPSNc43d1edb-c162-4317-9a89-d84e4eff551237
242438montelukast sodium 5 MG Chewable TabletPSNc43d1edb-c162-4317-9a89-d84e4eff551237
311759montelukast 4 MG Chewable TabletSCDc43d1edb-c162-4317-9a89-d84e4eff551237
242438montelukast 5 MG Chewable TabletSCDc43d1edb-c162-4317-9a89-d84e4eff551237
311759montelukast 4 MG (as montelukast sodium 4.2 MG) Chewable TabletSYc43d1edb-c162-4317-9a89-d84e4eff551237
242438montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable TabletSYc43d1edb-c162-4317-9a89-d84e4eff551237
200224montelukast sodium 10 MG Oral TabletPSNed2caffa-a75c-1c27-ae30-2d8280eaea7d22
311759montelukast sodium 4 MG Chewable TabletPSNed2caffa-a75c-1c27-ae30-2d8280eaea7d22
242438montelukast sodium 5 MG Chewable TabletPSNed2caffa-a75c-1c27-ae30-2d8280eaea7d22
200224montelukast 10 MG Oral TabletSCDed2caffa-a75c-1c27-ae30-2d8280eaea7d22
311759montelukast 4 MG Chewable TabletSCDed2caffa-a75c-1c27-ae30-2d8280eaea7d22
242438montelukast 5 MG Chewable TabletSCDed2caffa-a75c-1c27-ae30-2d8280eaea7d22
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSYed2caffa-a75c-1c27-ae30-2d8280eaea7d22
311759montelukast 4 MG (as montelukast sodium 4.2 MG) Chewable TabletSYed2caffa-a75c-1c27-ae30-2d8280eaea7d22
242438montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable TabletSYed2caffa-a75c-1c27-ae30-2d8280eaea7d22
200224montelukast sodium 10 MG Oral TabletPSN2f90a573-27fd-cc16-f3d1-8c4d630224a08
311759montelukast sodium 4 MG Chewable TabletPSN2f90a573-27fd-cc16-f3d1-8c4d630224a08
242438montelukast sodium 5 MG Chewable TabletPSN2f90a573-27fd-cc16-f3d1-8c4d630224a08
200224montelukast 10 MG Oral TabletSCD2f90a573-27fd-cc16-f3d1-8c4d630224a08
311759montelukast 4 MG Chewable TabletSCD2f90a573-27fd-cc16-f3d1-8c4d630224a08
242438montelukast 5 MG Chewable TabletSCD2f90a573-27fd-cc16-f3d1-8c4d630224a08
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSY2f90a573-27fd-cc16-f3d1-8c4d630224a08
311759montelukast 4 MG (as montelukast sodium 4.2 MG) Chewable TabletSY2f90a573-27fd-cc16-f3d1-8c4d630224a08
242438montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable TabletSY2f90a573-27fd-cc16-f3d1-8c4d630224a08
242438montelukast sodium 5 MG Chewable TabletPSN0f2dbf17-bce0-4e09-8c22-898d93be80da3
242438montelukast 5 MG Chewable TabletSCD0f2dbf17-bce0-4e09-8c22-898d93be80da3
242438montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable TabletSY0f2dbf17-bce0-4e09-8c22-898d93be80da3
242438montelukast sodium 5 MG Chewable TabletPSNa8261a89-d35b-357e-e053-2a95a90afcd01
242438montelukast 5 MG Chewable TabletSCDa8261a89-d35b-357e-e053-2a95a90afcd01
242438montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable TabletSYa8261a89-d35b-357e-e053-2a95a90afcd01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62175-205-326217502053230 TABLET, CHEWABLE in 1 BOTTLE (62175-205-32) 2012-08-030000-00-00NoNoCurrent
62175-205-43621750205431000 TABLET, CHEWABLE in 1 BOTTLE (62175-205-43) 2012-08-030000-00-00NoNoCurrent
62175-205-466217502054690 TABLET, CHEWABLE in 1 BOTTLE (62175-205-46) 2012-08-030000-00-00NoNoCurrent